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  4. Blood Products Advisory Committee March 21-22, 2018 Meeting Announcement - 03/20/2018 - 03/21/2018
  1. Advisory Committee Calendar

Advisory Committee Meeting

Event Title
Blood Products Advisory Committee March 21-22, 2018 Meeting Announcement
March 20 - 21, 2018

Date:
March 20 - 21, 2018
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Agenda
During the morning session on March 21, 2018, the Joint Committee will discuss and make recommendations regarding the device reclassification from Class III to Class II of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) infection. In the afternoon session, the Committee will hear an overview of the research presentations on the research programs of the Laboratory of Emerging Pathogens, the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents, and the Laboratory of Molecular Virology in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review Center for Biologics Evaluation and Research. After the open session, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

On March 22, 2018, the Joint Committee will discuss and make recommendations regarding the reclassification from Class III to Class II of nucleic acid and serology-based in vitro diagnostic devices indicated for use as aids in diagnosis of hepatitis C virus (HCV) infection and/or for use as aids in the management of HCV infected patients.

Meeting Materials
Materials for this meeting will be available at the Blood Products Advisory Committee meetings main page.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before March 14, 2018
  • Oral presentations on March 21, 2018 from the public will be scheduled between approximately 12:25 a.m. to 1:25 p.m. and 4:25 p.m. to 4:40 p.m. Oral presentations on March 22, 2018 from the public will be scheduled between approximately 11:15 a.m. to 12:15 p.m.
  • Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 6, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 7, 2018.
  • For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link.
    Blood Products Advisory Committee meeting March 21-22, 2018:
    https://collaboration.fda.gov/bpacmdac2018/

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington, DC, area). Please call the Information Line for up-to-date information on this meeting.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The link for the webcast will be available at 8 a.m. March 21, 2018 and 8:00 a.m. March 7, 2018 at the link above.  FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery or Joanne Lipkind at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Official FR Notice

Inclement Weather Advisory Guidance

Recorded Webcast

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

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